KPMP

This study is a multi-center, international, double-masked, placebo-controlled, parallel- group randomized clinical trial with T1D and moderate to advanced diabetic kidney disease. After a run-in period of 6 weeks, during which diabetes care will be standardized and education on monitoring and minimizing DKA completed, eligible study participants will be randomized in a 1:1 ratio to receive placebo or once daily 200 mg SOTA.

Purpose

Diabetic kidney disease (DKD) is the leading cause of kidney failure in the USA and developed world. Also, DKD is associated with a markedly higher risk of cardiovascular disease (CVD). The purpose of this study is to find out if a drug called Sotagliflozin (SOTA) can slow kidney function decline in persons with type 1 diabetes and moderate to severe DKD.

What You Will Do

If you join the study, you will:

• provide blood and urine samples
• wear a Continuous Glucose Monitoring (CGM) and provide CGM data to the study staff
• check your blood levels of beta-hydroxybutyrate (BHB or ketone body), and provide BHB data to the study staff.

Duration

• Treatment will be continued for 3 years and will be followed by an 8-week washout period.

Study Details